1. Field of the Invention
The present invention generally relates to medical devices and more particularly relates to packages for medical devices and methods therefor.
2. Description of the Related Art
During surgical procedures, great care is taken to prevent contamination of the surgical tools and medical devices used during the course of an operation. An operating team typically includes at least one member whose function is to open packages containing surgical tools and medical devices and to present them to a sterile nurse or surgeon in a manner whereby they remain in a sterile condition.
There have been many efforts directed to providing packages for medical devices that allow for efficient opening of the package and presentation of the medical devices to surgical personnel in a sterile condition. One type of package provides a color-marked envelope that indicates the area to be torn off to provide an access opening to the contents within the envelope without affecting the sterility of the contents. Another type of package provides a tear string that may be pulled to open the envelope so that the contents may be removed using forceps or another similar tool.
Packages for medical devices have also been provided having integral tear strips, which, when removed, not only sever the packages but provide delaminated margins on the exterior surfaces of the packages adjacent to the severed edges. It has been found that great care must be taken in the removal of the tear strip to avoid failure of the strip before the de-lamination is completed and the package is completely open. While a sterile surface area adjacent to the access area is provided by this method, the sterile area is limited in width to the delaminated margin which, of necessity, must be narrowed to prevent failure of the tear strip. Accordingly, the degree of care required in removing the contents of the package without contacting an unsterile surface surrounding the access area is, while lessened, still significant.
Commonly assigned U.S. Pat. No. 3,724,651 to Link discloses a peelable package for containing surgical tools and medical devices that may be sealed and sterilized within the package and subsequently removed therefrom with a minimum probability of contamination by the unsterile outer surfaces of the package. The package has two panels sealed together at their marginal portions to form a chamber therebetween having a sealed mouth and adjacent sealed edges. A section of the sealed marginal portions of one panel, extending across the mouth and along the adjacent edges of the package, is weakened, by scoring, so that upon opening the package, the weakened section of the panel will delaminate to the depth of the scoring in preference to yielding at the seal. The package is also provided with tabs extending beyond a sealed mouth. The tabs include bending scores which allow them to be folded away from the sterile portions of the package and additionally initiate the delamination of the panel when opening the package.
U.S. Pat. No. 5,878,549 to Littman et al. discloses an easy open tear control package, such as a pouch, made from a film of polymeric barrier material. The easy open tear control feature is formed from roughening portions of the outer and inner surface of the films, prior to fabricating the films into a package. The roughened portion is on one face or on each face of the package and is at least a full width of the seal when the film is made into the package. The roughened portion can extend the entire width of the package and can be of any desired length. With the package disclosed in the '549 patent, it is difficult to rapidly remove the contents of the package while maintaining sterility.
In spite of the above advances, there remains a need for an improved package for medical devices that is easy to open and that insures the contents inside the package are maintained in a sterile environment. In addition, there remains a need for an improved package, such as a foil pouch, that may be easily opened in a surgical environment for efficiently presenting medical devices or tools to surgical personnel. There also remains a need for a package that provides a clear indication of the end of the package that is to be opened for efficiently accessing the medical devices for use during a surgical procedure. Moreover, there remains a need for a package that facilitates loading a medical device inside the package, as well as a need for improved methods for packaging medical devices and tools.